Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medical device for SNM: Interstim X or Interstim micro.
- Who it may be relevant to
- Registry conditions: Bladder Hyperactivity, Sacral Neuromodulation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Overactive bladder syndrome (OAB) is defined by urgent and frequent urges to urinate associated with frequent night-time urination and sometimes urinary incontinence. Sacral neuromodulation (SNM) is now one of the second-line treatments for OAB. The mode of action of SNM is still poorly understood but a number of data from recent scientific literature suggest that SNM may act, among other things, by altering the balance of the autonomic nervous system (ANS) - located at the interface between the urinary tract and the brain structures regulating the functioning of the urinary tract. The aim of this study would therefore be to develop a predictive tool for the effectiveness of SNM.
Interventions
- Device Medical device for SNM: Interstim X or Interstim micro
ANI will be used during the SNM (2 hours)
Primary outcome measures
- Comparison of HFVI analysed through HRV at baseline and during standardized stimulation protocol randomly delivered at the level of the 4contact points of the quadripolar lead at the time of lead implantation between the effective and noneffective groups [Time frame: 1 year]
Secondary outcome measures (2)
- SDNN (Standard Deviation of all normal-to-normal RR intervals (milliseconds)) and RMSSD (Root Mean Square of Successive Differences between normal-to-normal RR intervals (milliseconds)) at baseline and during standardized electrical stimulation [Time frame: 1 year]
- LF (Low-Frequency power of heart rate variability (ms²)) and HF (High-Frequency power of heart rate variability (ms²)) components of heart rate variability at baseline and during standardized electrical stimulation [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Male of female ≥ 18 years
- OAB syndrome
- Indication for a two-staged SNM
- Under general anaesthesia with Remifentanil and Propofol
- Patient who has given written consent to participate in the trial
- Patient willing to comply with all study procedures and duration
Exclusion criteria
- Tibial neuro-stimulation (last 3 months)
- Sacral neuromodulation (last 3 months)
- Botulinum toxin A intra-detrusor injection (last 9 months)
- Pregnancy in progress
- Administrative reasons
- Guardianship/curatorship
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- chu de Lille — Lille
Identifiers
NCT: NCT06434831 · 2023_195